The PD Life Study: Exploring the Treatment Burden and Capacity of People With Parkinson's and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Treatment Burden Levels
研究概览
简要总结
Background:
People with Parkinson's (PwP) have many symptoms including tremor, stiffness, slow movements, constipation, urinary incontinence and mental health issues. They are often older and have other long-term health conditions. PwP need to do many things to look after their health including manage multiple medications, attend healthcare appointments and lifestyle changes such as improving diet and exercise.
The effort of looking after their health and its impact on them is termed 'treatment burden'. Some PwP need help from their family or friends (caregiver) to complete these tasks. Caregivers may also experience treatment burden themselves when caring for someone with Parkinson's. People's ability to manage treatment burden is termed 'capacity' and is influenced by physical, mental, social and economic factors. People are overburdened when the workload of looking after their health exceeds their capacity. This can lead to poor adherence with treatment, poor quality of life and worse health outcomes.
Aim:
To understand the factors that influence treatment burden and capacity in PwP and caregivers of PwP.
Methods:
Interviews with PwP and caregivers will identify factors that influence treatment burden and capacity. These factors will be explored further in a national survey for PwP and caregivers through Parkinson's UK. The investigators will form focus groups with PwP, caregivers, voluntary sector representatives, healthcare professionals, policy makers and managers through Parkinson's Excellence Networks to discuss and prioritise recommendations for change.
Outcomes:
The investigators will disseminate recommendations of ways to reduce treatment burden and improve future experiences of PwP and caregivers.
详细描述
This is a mixed-methods study that will be conducted over three work packages as described below and will be completed in 24 months. The investigators will have patient and public involvement throughout the study.
Work Package 1 - Interviews:
The investigators will interview 15-20 PwP and 15-20 caregivers (face-to-face, telephone or video calls) recruited from Parkinson's clinics in Hampshire and Dorset to identify factors that influence treatment burden and capacity among PwP and caregivers of PwP. Participants will be eligible to take part in the study if they have a diagnosis of Parkinson's or is a caregiver for someone with Parkinson's, and able to give informed consent. The investigators will use purposive sampling to include both genders, a range of ages, severity of Parkinson's and caregiver relationships. Potential eligible participants will be identified by the clinical team. Written consent will be obtained prior to each interview. Interviews will be audio-recorded and transcribed. The investigators will take an inductive approach to identify emerging themes until no new information arises.
Work Package 2 - National Survey:
Results from the interviews will then inform the development of a national survey for PwP and caregivers. The national survey will for the first time quantify treatment burden using the Multimorbidity Treatment Burden Questionnaire (MTBQ) and capture aspects of capacity such as severity and duration of Parkinson's, social and economic resources, medications, frailty and health literacy. Participants with mild, moderate and severe Parkinson's will be recruited with agreed support from Parkinson's UK and from Parkinson's clinics. Participants will be eligible to take part in the study if they have a diagnosis of Parkinson's or is a caregiver for someone with Parkinson's, and able to give informed consent. Each participant will be able to complete a separate survey online or on paper.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People diagnosed with Parkinson's or caregiver of someone diagnosed with Parkinson's
- •Able to consent to participate
排除标准
- •Unable to consent to participate
- •For Work Package 3:
- •Inclusion Criteria:
- •Have a role in the care of someone with Parkinson's including but not limited to people diagnosed with Parkinson's, caregiver of someone with diagnosed with Parkinson's, healthcare professionals, volunteer sector representative, policy maker or manager
- •Able to consent to participate.
- •Exclusion criteria:
- •Unable to consent to participate
结局指标
主要结局
Treatment Burden Levels
时间窗: 24 months
Treatment burden levels will be measured using the Multimorbidity Treatment Burden Questionnaire (MTBQ):- Overall scores (0-100) categorised as no burden (score 0), low burden (score \<10), medium burden (10-22) and high burden (\>=22).
Treatment Burden Experiences
时间窗: 24 months
The investigators will describe the key factors that influence participants' experiences of treatment burden
Capacity
时间窗: 24 months
The investigators will describe the key factors that influence participants' capacity
次要结局
- Multimorbidity and treatment burden levels(24 months)
- Frailty and treatment burden levels(24 months)
- Severity of Parkinson's and treatment burden levels(24 months)